- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00098215
Pediatric Residency Training On Tobacco
Pediatric Residency Training on Tobacco
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The American Academy of Pediatrics and other leading health agencies call upon pediatricians to address environmental tobacco smoke (ETS), prevent smoking onset in youths, and encourage cessation of tobacco use by adolescents and their parents. Systematic intervention on tobacco by pediatricians would protect infants and young children from the harmful effects of ETS and save adolescents from a lifetime of addiction and tobacco-related disease. Despite this, few pediatricians address tobacco use, and pediatric residency training programs are not preparing residents to play a leadership role in the anti-tobacco arena.
The Pediatric Residency Training on Tobacco project is a four-year randomized controlled study of the efficacy of a specialized tobacco intervention program for pediatric residents. Eight participating pediatric training sites were randomly assigned to a Special Training condition featuring "Solutions for Smoking", a hybrid CD-ROM/Website training program. Six sites were randomly assigned to a control condition that provided standard print literature. Key features of "Solutions for Smoking" include a website containing background material on tobacco, interviewing, behavioral and pharmacological aspects of intervention, and a series of CD-ROMs containing audio-visual vignettes that model state-of-the-art interviewing and tobacco intervention skills. Residents are expected to practice the interventions with patients in their Continuity Clinics, and all sites are provided with brochures and other intervention materials for this purpose. Study investigators meet with residents at all sites three times per year to discuss the program and the residents' efforts to intervene on tobacco with their patients. Annually, second and third-year residents participate in Objective Structured Clinical Examinations (OSCEs) and a Resident Tobacco Survey. Patients and parents attending each of the Continuity Clinics complete Patient and Parent Tobacco Surveys at baseline and end of study.
Primary endpoints include changes over time in pediatric residents' tobacco intervention knowledge, skills, and activities as reported on the Tobacco Surveys and measured by performance on the OSCEs at baseline and follow-up. Secondary endpoints include changes in smoking, other tobacco use, and control of ETS by patients and parents. The study hypothesizes that pediatric residents in both arms of the study will be similar in knowledge and skills at baseline; that residents in the specialized training program will acquire more knowledge and greater skills for tobacco intervention during the course of the study compared to residents in the control condition; and residents in each condition will increase the frequency in which they address tobacco in patients and parents.
Tipo de estudo
Inscrição
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103-1489
- Recrutamento
- UMDNJ-Robert Wood Johnson Medical School
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Contato:
- William Graessle, MD
- Número de telefone: 856-342-2472
- E-mail: Graessle-Bill@cooperhealth.edu
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Jersey City, New Jersey, Estados Unidos, 07304
- Recrutamento
- Mount Sinai School of Medicine (Jersey City Program)
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Contato:
- Richard Bonforte, MD
- Número de telefone: 201-915-2455
- E-mail: rbonforte@libertyhcs.org
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Neptune, New Jersey, Estados Unidos, 07754
- Recrutamento
- Jersey Shore Medical Center
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Contato:
- Alan Cabasso, MD
- Número de telefone: 732-776-4269
- E-mail: jsmcped@aol.com
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Newark, New Jersey, Estados Unidos, 07112
- Recrutamento
- Newark Beth Israel Medical Center
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Contato:
- Joshua S Rosenblatt, MD
- Número de telefone: 973-926-7040
- E-mail: josh@bethi.com
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Paterson, New Jersey, Estados Unidos, 07503
- Recrutamento
- St. Joseph's Hospital and Medical Center
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Contato:
- Thomas Daley, MD
- Número de telefone: 973-754-2619
- E-mail: daleyt@sjhmc.org
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New York
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Bronx, New York, Estados Unidos, 10451
- Recrutamento
- Lincoln Medical Center
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Contato:
- Hermann Mendez, MD
- Número de telefone: 718-780-1025
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Bronx, New York, Estados Unidos, 10457
- Recrutamento
- Bronx/Lebanon Hospital
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Contato:
- Ronald Bainbridge, MD
- Número de telefone: 718-518-5760
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Brooklyn, New York, Estados Unidos, 11201
- Recrutamento
- Long Island College Hospital
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Contato:
- Umit Emre, MD
- Número de telefone: 718-780-1025
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Brooklyn, New York, Estados Unidos, 11206-5317
- Recrutamento
- Woodhull Medical and Mental Health Center
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Contato:
- John Moohr, MD
- Número de telefone: 718-963-8778
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Brooklyn, New York, Estados Unidos, 11212
- Recrutamento
- Brooklyn Hospital Center Program
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Contato:
- Theodoros Raptis, MD
- Número de telefone: 718-250-6209
- E-mail: mjs9005@nyp.org
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East Meadow, New York, Estados Unidos, 11554
- Recrutamento
- Nassau County Medical Center
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Contato:
- Stephen P Katz, MD
- Número de telefone: 516-572-6177
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Flushing, New York, Estados Unidos, 11355
- Recrutamento
- New York Flushing Hospital Medical Center
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Contato:
- Fatema Meah, MD
- Número de telefone: 718-670-3145
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Mineola, New York, Estados Unidos, 516-663-2288
- Recrutamento
- Winthrop-University Hospital Program
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Contato:
- Stephen Marino, DO
- Número de telefone: 516-663-4423
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New York City, New York, Estados Unidos, 10021
- Recrutamento
- New York and Presbyterian Hospital (Cornell Campus) Program
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Contato:
- Susan Bostwick, MD
- Número de telefone: 212-746-3522
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
The training program will include all residents enrolled in the 14 participating residency training programs.
The Baseline and Follow-up Resident Tobacco Surveys and OSCEs will include all second and third year residents enrolled in the residency training programs at baseline and years 1, 2, and 3 of follow-up.
The Baseline and Follow-up Patient Tobacco Survey will include 30 patients, ages 12-21, who were present in the waiting areas of the Continuity Clinic when the surveys were administered. All patients present in the clinic will be approached and invited to participate. Partcipants must be able to read English or Spanish, and patients who are attending the clinic for the very first time will not be eligible to participate in the survey.
The Baseline and Follow-up Parent Tobacco Surveys will be administered to 100 parents (one per family) who are present in the clinic when the surveys are administered. Parents who cannot read English or Spanish and who are bringing their child to the clinic for the very first time will not be able to participate.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Educacional/Aconselhamento/Treinamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph Schwab, M.D., New Jersey Medical School
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R01HD40683-1
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